Updated: Tuesday October 11, 2016/AthThulatha
Muharram 10, 1438/Mangalavara
Asvina 19, 1938, at 03:18:48 PM
The Drug Regulatory Authority of
Act No. XXI OF 2012
An Act to provide for the establishment of Drug
Regulatory Authority of Pakistan
WHEREAS it is expedient to establish a
Drug Regulatory Authority of Pakistan to provide for effective co-ordination
and enforcement of The Drugs Act, 1976 (XXXI of 1976) and to bring harmony in
inter-provincial trade and commerce of therapeutic goods;
AND WHEREAS it is expedient to
regulate, manufacture, import, export, storage, distribution and sale of
therapeutic goods;
AND WHEREAS the Provincial Assemblies
of Khyber Paktunkhwa,
It is hereby enacted as follows:---
CHAPTER-I
PRELIMINARY
1. Short title, extent and commencement.___(1)
This Act may be called the Drug Regulatory Authority of Pakistan Act, 2012.
(2) It extends to the whole of
(3) It shall come into force at once.
2. Definitions. In this Act, unless there is anything repugnant in
the subject or context,---
(i) “Act”
means the Drugs Act, 1976 (XXXI of 1976);
(ii) “Alternative Medicine” means a product used
exclusively in Homeopathic, Unani, Ayurvedic, Biochemic, Chinese or other
traditional system of treatment;
(iii) “Appellate
Board” means an Appellate Board constituted under Section 12 for the disposal
of appeals against the decisions of the Licensing Board or the Registration
Board or Pricing Committee;
(iv) “Authority”
means the Drugs Regulatory Authority of Pakistan established under Section 3;
(v) “Biologicals”
means biological drugs as defined in Schedule-I;
(vi) “Board”
means the Policy Board of the Authority constituted under Section 9;
(vii) “CEO”
means the Chief Executive Officer of the Authority appointed under Section 5;
(viii) “Chairperson”
means the Chairperson of the Board;
(ix) “civil
servant” means a civil servant as defined in the Civil Servants Act, 1973 (LXXI
of 1973);
(x) “decision”
includes an order, determination or direction of the Authority or the Board
made in accordance with laws, rules and regulations;
(xi) “Director”
means director of a department of the Authority;
(xii) “drug”
means drug as defined in Schedule-I;
(xiii) “fee”
means fee prescribed by the Board for any service;
(xiv) “Fund”
means the Drug Regulatory Authority of Pakistan Fund created under Section 19;
(xv) “health
and OTC Products (non-drugs)” include probiotics and disinfectant, nutritional
products, food supplements, baby milk and foods, medicated cosmetics, medicated
soaps and medicated shampoos;
(xvi) ”Inspector” means the Inspector appointed under
the Act as specified in Schedule-V;
(xvii) ”Licensing
Board” means a Licensing Board constituted under Section 7 sub-section (u) of
this Act to regulate the grant of licenses for the manufacture of therapeutic
goods;
(xviii) “Medical
Device” means medical devices as specified in Schedule-I;
(xix) “Medicated
Cosmetics” means cosmetics containing drugs as specified in Schedule-1;
(xx) “Member”
means a member of the Board;
(xxi) “OTC”
mean over-the-counter non-prescription products;
(xxii) ”penalty”
means penalty as specified in Schedule III;
(xxiii) ”person”
means any individual or any legal entity;
(xxiv) “Pension
Endowment Fund” means an endowment fund separate from the Fund of the Authority
dedicated only for the payment of pension benefits of Authority”s employees;
(xxv) “pharmaceutical
field” means regulation, manufacturing, quality control, quality assurance,
research, academia, import, export, and pharmacy services in drugs;
(xxvi) ”pharmacy
services” means services rendered by a pharmacist in pharmaceutical care,
selection, posology, counseling, dispensing, use, administration, prescription
monitoring, pharmacoepidemiology, therapeutic goods information and poison
control, pharmacovigillance, pharmacoeconomics, storage, sales, procurement,
forecasting, supply chain management, distribution, drug utilization
evaluation, drug utilization review, formulary based drug utilization and
managing therapeutic goods at all levels including pharmacy, clinic, medical
store, hospital or medical institution;
(xxvii) “pharmaceutical evaluation” means the assessment of a
detailed pharmaceutical dossier submitted for the registration of a therapeutic
good;
(xxviii) “pharmaceutical
dossier” means a set of documents, as specified in Schedule-I;
(xxix) “prescribed” means
prescribed by rules or regulations under this Act;
(xxx) “Prohibitions” means
Prohibitions as specified in Schedule-II;
(xxxi) “regulation” means the
regulations made under this Act;
(xxxii) “Registration Board”
means a Registration Board constituted under Section 7 sub-section (u) of this
Act to regulate the grant of registration to therapeutic goods;
(xxxiii) “rules” means the
rules made under this Act;
(xxxiv) “Secretary” means
Secretary of the Board;
(xxxv) “Schedule” means
Schedule to this Act; and
(xxxvi) “Therapeutic goods”
includes drugs or alternative medicine or medical devices or biologicals or
other related products as may be notified by the Authority.
CHAPTER-II
AUTHORITY AND BOARD
3.
Establishment of the Authority.___(1) As soon as may be, after the commencement of this
Act, the Federal Government shall, by notification in the official Gazette,
establish an Authority to be known as the Drug Regulatory Authority of
Pakistan, to carry out the purposes of this Act.
(2) The
Authority shall be a body corporate having perpetual succession and a common
seal, and may sue and be sued in its own name and, subject to and for the
purposes of this Act, may enter into contracts and may acquire, purchase, take,
hold and enjoy moveable and immovable property of every description and may
convey, assign, surrender, yield up, charge, mortgage, demise, reassign,
transfer or otherwise dispose of or deal with, any moveable or immovable
property or any interest vested in it.
(3) The
Authority shall be an autonomous body under the administrative control of the
Federal Government with its headquarters at
(4) The
Authority may set up its establishments including sub-offices and laboratories
at provincial capitals and such other places, as it may deem necessary from
time to time. The existing Federal Drugs Control Administration and the
sub-offices set up in all provinces and laboratories called the Central Drugs
Laboratory,
(5) The
common seal of the Authority shall be kept in the custody of the Chief
Executive Officer or such other person as may be prescribed by regulations and
documents required or permitted to be executed under the common seal shall be
specified and authenticated in such manner as may be prescribed by regulations.
4.
Composition of the Authority.___(1) The Authority shall consist of a full time Chief
Executive Officer (CEO) and thirteen Directors who shall be appointed by the
Federal Government on the recommendation of Board, whose qualifications, terms
and conditions shall be such as may be prescribed. The Directors shall be
designated as:---
(a) Director Pharmaceutical
Evaluations and Registration.--He shall be incharge of the Division of
Pharmaceutical Evaluations and Registration which shall be responsible for the
evaluation, assessment and registration of Pharmaceuticals drugs for human
beings, animals and to perform other functions connected therewith and assigned
by the Board;
(b) Director Drug
Licensing.--He shall be the incharge of the Division of Drug Licensing which
shall be responsible for the licensing of the drugs manufacturing facilities
and to perform other functions connected therewith;
(c) Director Quality
Assurance and Laboratory testing.--He shall be incharge of the Division of
Quality Assurance and Laboratory testing which shall be responsible for
enforcement of current Good Manufacturing Practices under the Act, and for
testing or research of drugs and to perform other functions connected
therewith. The Division will also perform the functions related to post
marketing surveillance and shall be responsible for the evaluation,
co-ordination and monitoring of safety, efficacy and quality of registered
drugs and inactive materials including the clinical and toxicological study,
drug recalls and with drawls, and to perform other functions connected
therewith;
(d) Director Medical
Devices and Medicated Cosmetics.--He shall be incharge of the Division of
Medical Devices and Medicated Cosmetics which shall be responsible for the
assessment, enlistment or registration of medical devices and medicated
cosmetics, medicated shampoos and medicated soaps for human beings, animals and
to perform other functions connected therewith;
(e) Director Biological
Drugs.--He shall be incharge of the Division of Biological Evaluation and
Research which shall be responsible for the evaluation, assessment,
registration and licensing of Biologicals for human beings, animals and to
perform other functions connected therewith including all the functions of
national control authority for biologicals as required for the prequalification
by World Health Organizations of locally manufactured human biological drugs;
(f) Director Controlled
Drugs.--He shall be incharge of the Division of Controlled Drugs which
shall in consultation with the Federal Government be responsible for regulation
and allocation of quota of narcotic drugs, psychotropic substances and
precursor chemicals and to perform other functions connected therewith;
(g) Director
Pharmacy Services.--He shall be incharge of the Division of Pharmacy
Services which shall be responsible for the development and promotion of
pharmacy services and to perform other functions connected therewith;
(h) Director Health and
OTC Products (non-drugs).--He shall be incharge of the Division of Health
and OTC Products (non-drugs) which shall be responsible for the assessment,
licensing and registration of Alternative Medicines such as Ayurvedic, Chinese,
Unani and Homeopathy, enlistment or registration of nutritional
products and food supplements for human beings, animals and to perform other
functions connected therewith;
(i) Director Costing
and Pricing.--He shall be incharge of the Division of Costing and Pricing
which shall be responsible for the costing and pricing of therapeutic goods and
to perform other functions corrected therewith;
(j) Director Budget and
Accounts.--He shall be incharge of the Division for Budget and Accounts
which shall be responsible for budgetary and financial aspects of the Authority
and other daily accounting matters connected therewith or ancillary thereto;
(k) Director
Administration, Human Resource and Logistics.--He shall be incharge of the
Division for Administration, Human Resource and Logistics which shall be
responsible for administration, recruitment, appointment, capacity building and
development for the Authority and other matters connected therewith and
ancillary there to;
(l) Director Legal
Affairs.--He shall be incharge of the Division for Legal Affairs which
shall be responsible for legal aspects of the Authority and other matters
connected with Drug Court and other Court cases therewith or ancillary thereto;
and
(m) Director Management
Information Services.--He shall be incharge of the Division for Management
Information Services which shall be responsible for development of automation
of functions using information technology for the Authority and other matters
connected therewith and ancillary there to;
(2) The
Federal Government, on the recommendations of the Board may increase or
decrease the number of Divisions or Director and prescribe their functions and
the relevant experience, qualification, terms, mode and manner of appointment
of Directors and related staff in each Division.
5.
Chief Executive Officer.(1) The Federal
Government may, on the recommendations of the Board appoint a person as Chief
Executive Officer who,---
(a) has a post graduate
degree in Pharmacy or medicine with an age not less than 45 years or more than
56 years, with a minimum of twenty years experience in management or
pharmaceutical field or regulatory affairs, in public sector, or if no such
person of aforesaid qualifications is available in the public sector, then a
person possessing above qualifications and experience from the private sector;
(b) the tenure of
appointment of CEO shall be for a period of three years, extendable on the
recommendation of the Board for one year only; and
(c) the CEO shall exercise
general Control and supervision over the affairs of the Authority and shall
ensure the provisions of the Act, the rules, and that the regulations, policies
and directions of the Board are properly executed;
(2) The
CEO shall discharge such duties and perform such functions as are assigned to
him by or under this Act or as may be prescribed by the Board and in particular
shall,---
(a) keep in custody the
records and seal of the Authority;
(b) submit plan of work
and budget estimates of the Authority for approval of the Board; and
(c) submit to the Board,
in accordance with the rules and regulations reports on the activities of the
Authority.
(3) The
CEO shall also have the power to,---
(a) supervise the
activities connected with the execution of programs for training, research,
institutional consultancies, and other services;
(b) authorize expenditure
provided for in the budget in accordance with the rules and regulations;
(c) re-appropriate funds
within the approved budget;
(d) delegate his powers to
appropriate levels of management subject to such conditions as he may deem fit;
(e) issue notices of meetings
of the Board and Appellate Board and to maintain proper record of the minutes
and proceedings thereof;
(f) execute deeds and
documents on behalf of the Board; and
(g) perform any other duty
assigned to him by the Board.
(4) The
CEO shall not, except with the prior approval of the Board in each case or
unless already approved in the budget duly itemized, allow expenditure on items
of civil works, or capital expenditure on office or laboratory equipment or
automobiles,
(5) The
CEO may tender his resignation under his own hand.
(6) In
case of occurrence of vacancy of CEO the Federal Government is authorised to
appoint any person having prescribed qualification as CEO for a period of three
months or till the appointment of CEO, whichever is earlier.
6. Meeting
of the Authority.(1) Save as hereinafter
provided, the Authority shall regulate the procedure for its meetings.
(2) The
meetings of the Authority shall be convened by the CEO at any time on his own
or as directed by the Policy Board on any matter requiring decision by the
Authority.
7.
Powers and functions of the Authority. The powers and functions
of the Authority shall be to,---
(a) administer the laws
specified in the Schedule-VI that apply to Federal Government, and advise the
Provincial Governments for the laws that are applicable to the Provinces;
(b) monitor the
enforcement of laws specified in the Schedule-VI and collect relevant data and
information;
(c) issue guidelines and
monitor the enforcement of,---
(i) licensing of the
manufacture of therapeutic goods;
(ii) registration of
therapeutic goods;
(iii) regulation for the
advertisement;
(iv) drug specifications
and laboratory practices;
(v) prosecution and
appeals under this Act and the Drugs Act, 1976 (XXXI of 1976) relating to
Federal subject;
(vi) regulation and
allocation of quota of narcotic drugs, psychotropic substances and precursor
substances (chemicals) in consultation with Federal Government;
(vii) regulation for pricing
and mechanism for fixation of prices of various therapeutic goods under its
ambit;
(viii) determining standards
for biological manufacturing and testing;
(ix) implementation of
internationally recognized standards such as good laboratory practices, current
good manufacturing practices, good distribution practices, cold chain
management, bioequivalence studies, stability studies, anti-spurious codes,
clinical trials, biosimilar evaluations, and endorsement and systematic
implementation of World Health Organization, International Confer-ence on
Harmonizations and Food and Drug Administration guidelines etc.;
(x) regulation,
enforcement and monitoring of advertisement rule and ban on false
advertisement;
(xi) manufacturing of
active pharmaceutical ingredients in all its forms; and
(xii) use of central
research fund.
(d) coordinate, monitor or
engage, in conjunction with other organizations, Provincial Governments and
international agencies, in training, study or project related to therapeutic
goods. The Authority may engage any individual or counsel to advise or work for
managing national and international opportunities for training, education,
seminars, conferences etc., with a view to improve capacity building;
(e) facilitate advancement
and up gradation of the sector to meet international standards and also to
promote manufacture and export of active pharmaceutical ingredients and
therapeutic goods;
(f) coordinate at policy
level and provide policy guidance to the Provincial Government in the
performance of their functions with a purpose to bring uniformity;
(g) facilitate the
procurement and implementation of foreign aided technical assistance on
therapeutic goods where such expertise does not exist but its existence would
promote public good;
(h) take steps for
development and promotion of pharmacy services;
(i) undertake awareness
campaigns regarding prevention of diseases, patients' rights, healthcare
privileges etc., through media, seminars, publications, and other available
means of information technology;
(j) issue guidelines and
monitor proceedings and funding and accounts of health seminars, workshops and
conferences;
(k) advise the Federal
Government on issues related to obligations and commitments related to
therapeutic goods;
(l) appoint such
employees, consultants and experts as deemed necessary on prescribed terms and
conditions including their salaries and remunerations with consultation and
approval of the Board. Such recruitment, continuation and remuneration shall be
based on merit and productivity;
(m) prescribe rules for
seniority, promotion, code of conduct and terms and condition of service of its
employees;
(n) levy such charges or
fees as may be prescribed for services and facilities provided by the Authority
and its offices;
(o) enter into contract
for the supply of materials or for the execution of works as may be necessary
for the discharge of any of its duties and functions;
(p) prepare annual budget
to be approved by the Board;
(q) to monitor and
regulate the marketing practices, so as to ensure rational use of drugs, and
ethical criteria for promotion of therapeutic goods in line with international
practices;
(r) develop working
manuals, guidelines, references, materials and procedures in order to improve
the working environment of offices etc., set up under the Authority;
(s) prescribe, regulate or
implement measures and standards on matters related or connected with the
Authority;
(t) develop, issue, adopt,
and enforce the standards and guidelines to ensure safety, efficacy, and
quality of therapeutic goods with rational use at reasonable price;
(u) perform licensing,
registration, pricing and appellate function thereof;
(v) coordinate with
Provincial Governments and International agencies for smooth implementation of
laws, capacity building and training of the regulatory staff;
(w) develop standard
operating procedures, manuals, guidelines for transparent working of offices
and conduct quality audits for conformance of the same;
(x) establish system of
cost recovery to ensure financial autonomy and efficient functioning of the
authority without becoming burden on the Government; and
(y) perform and carry out
any other act, duty or function as may be assigned to it by the Policy Board
and the Federal Government for furthering the provisions of this Act.
8.
Delegation of powers. The Authority may with
the approval of the Board, by general or special order in writing subject to
such conditions or limitations, delegate any of its powers and functions to any
of its officers as it may deem appropriate.
9.
Policy Board.(1) The general
direction, administration and monitoring of the Authority shall vest in the
Policy Board which shall consist of fifteen members, namely:---
|
(a) Secretary of the concerned Division (Federal
Secretary BS-22) |
Chair person |
|
(b) CEO |
Member |
|
(c) Representative of
Ministry of Law and Justice not below BPS-20 |
Member |
|
(d) Secretary of the
concerned Department, Government of the Balochistan |
Member |
|
(e) Secretary of the
concerned Department, Government of the Sindh |
Member |
|
(f) Secretary of the
concerned Department, Government of the Khyber Pakhtunkhwa |
Member |
|
(g) Secretary of the
concerned Department, Government of the |
Member |
|
(h) Secretary of the
concerned Department, Government of the Gilgil-Bultistan |
Member |
|
(i) Representative
from Federally Administered Tribal Area |
Member |
|
(j) Six experts from
the public and private sector with equal representation from each Province,
these members shall be from different specialties as defined in sub-section
(3) below. |
Member |
(2) The
CEO shall also be the Secretary of the Board. The Board shall look after and be
responsible for the affairs of the Authority.
(3) The
Federal Government shall, by notification in the official Gazette, appoint six
expert members, with representation from the Provinces, under Clause (j) of
sub-section (1) preferably one from each province having specialty in the
fields of drug manufacturing, quality control, drug regulation, public health,
pharmacy services, health finance, health economics, health management,
pharmacology, or biotechnology:
Provided
that unless earlier removed by the Federal Government the term of the expert
member shall be two years and shall be eligible for one more similar term only.
The expert member may resign his office by writing under his hand addressed to
the Federal Government:---
Provided
further that the expert member shall himself attend the meeting and shall not
send a representative;
(4) No
act or proceeding of the Board shall be invalid by reason only if the existence
of a vacancy in the constitution of the Board.
(5)
Notwithstanding the composition of the Board constituted by the Federal
Government under sub-section (1), the Board may increase or decrease the number
of its members and prescribe the qualifications and procedure for their
appointment.
10.
Meeting of the Policy Board.(1) The meetings of the
Board shall be convened by the Secretary of the Board with the prior approval
of the Chairperson. In case of absence of the Chairperson, the members present
may elect the Chairperson for that meeting.
(2) The
meetings of the Board shall be held at twice a year or more as and when
required. A special meeting may also be called at any time to deal with any
urgent business.
(3) Save
as hereinafter provided, the Board shall make regulations for the conduct of
its business.
(4) A
simple majority of the total membership shall constitute the quorum for a
meeting of the Board and in case of equality of votes, the Chairperson or the
person presiding over the meeting shall have a casting vote.
(5) All
decisions or determinations taken by the Board shall be recorded in writing.
(6) The
Board meeting shall be called by giving an advance notice of at least seven
days.
11.
Functions of the Board.(1) The Board shall
have the following functions, namely:---
(a) frame the policy and
provide guidelines based on global and regional trends to the Authority and
monitor the implementation and performance of the guidelines and of the
functions of the Authority ensuring good governance and accountability;
(b) monitor and supervise
all the functions of the Authority;
(c) approve the Budget of
the Authority; and
(d) determine all fees and
levies.
12.
Appellate Board and Committees of the Policy Board.(1) The Board may
constitute Appellate Board and Committees of experts as it considers necessary
or expedient to assist it in the performance of its functions under this Act.
(2) A
Board and Committee constituted under sub-section (1) shall act in accordance
with the regulations made by the Board.
13.
Invitation by Board. The Board may invite any person to attend its meeting
or deliberations including any meeting of the Appellate Board or its Committees
constituted under Section 12, for the purpose of advising it on any matter
under discussion but such person shall have no right to vote at the meeting or
deliberation.
14.
Appointment of officers and employees etc., of the Authority.(1) The Authority, with
approval of the Board, may create posts and appoint such officers, employees,
experts and consultants, as it may consider necessary, for the performance of
its functions in the prescribed manner. The criteria for recruitment and
selection of employees and officers will be determined by the Board according
to the rules as prescribed.
(2) The
age of superannuation for each employee shall be sixty years.
(3) No
person shall be appointed as the CEO or Director of the Authority unless he is
a citizen of
15.
Integration of Federal Drugs Control Administration its sub-offices and
Laboratories.(1) Upon the
commencement of this Act the Drugs Control Administration, its sub-offices and
its Laboratories hereinafter referred to as the said offices as referred in
sub-section (4) of Section 3 shall become part of the Authority.
(2) All
assets, rights, powers, authorities and privileges and all properties, movable
and immovable, cash and bank balance, reserve funds, investment and all other
interest rights in, or arising out of such properties and all debts,
liabilities and obligation of whatever kind of the said offices subsisting
immediately before there integration shall stand transferred to and vest in the
Authority.
(3) All
debts and obligation incurred or contracts entered into or rights acquired and
all matters and things engaged to be done by, with or for the said offices
before their integration, shall be deemed to have been incurred, entered into,
acquired or engaged to be done by for the Authority.
(4) All
suits and other legal proceedings instituted by or against the said offices
before their integration shall be deemed to be suits and proceedings by or
against the Authority and may be proceeded or otherwise dealt with accordingly.
(5)
Notwithstanding anything contained in any contract or agreement or in the
conditions of services,---
(a) every employee of the
said offices under the Federal Government immediately after the commencement of
this Act shall be required to exercise an irrevocable option either to continue
in the present pay and service structure as a civil servant or to opt for
absorption in the Authority within a period of thirty days from the date of
commencement of this Act;
(b) all employees who opt
to be included in the Authority under its rules shall be governed by this Act
and the terms and conditions so prescribed;
(c) no health personnel
who opts to be governed under this Act shall be entitled to any compensation
because of such transfer; and
(d) the terms and
conditions of service of all officers and staff employed in the Drug Regulatory
Agency of Pakistan under Ordinance (I of 2012) before the commencement of this
Act shall not be varied to their disadvantage under the Authority.
16.
Experts, consultants and advisers not to be civil servants. The experts,
consultants, employees or advisers employed by the Authority shall be governed
by the terms and conditions of their appointment and shall not be deemed to be
civil servant within the meaning of Civil Servants Act, 1973 (LXXI of 1973).
17.
CEO and officers etc., to be public servants. The CEO officers, employees, experts and consultant of
the Authority shall, when acting or purporting to act in pursuance of any of
the provisions of this Act, be deemed to be public servants within the meaning
of Section 21 of the Pakistan Penal Code (Act, XLV of 1860).
18.
Conflict of interest.(1) No person shall be
appointed as CEO, Director, consultant, advisor, officer or employee of the
Authority if he or she has any financial or professional conflict of interest.
(2) No
person shall be member of the Board or Director if he has immediate family
members (parent, child, sibling or spouse) as senior officials or owners of
concerns dealing in therapeutic goods.
CHAPTER-III
FUND, BUDGET AND
ACCOUNTS
19.Drug
Regulatory Authority of
(2) The
Drug Regulatory Authority Funds shall be financed from the following sources
namely:---
(a) grant-in-aid in terms
of salaries and retirement benefits of the existing staff to be provided by the
Federal Government;
(b) donations and
endowments;
(c) grants and loans by
the Federal Government or a Provincial Government;
(d) loans and grants from
the national and international agencies received by the Federal Government and
Provincial Governments to finance the function of the Authority;
(e) charges and fees
collected by the Authority to recover the costs of regulated activities under
this Act;
(f) proceeds of any
investments made by the Authority which are not required for immediate use. All
investments to be made by the Authority shall be with the approval of the
Board;
(g) proceeds from any
other service rendered by the Authority, including Inspection Services, foreign
or local, or sale of any publication; and
(h) Central Research
Fund collected from the pharmaceutical industry.
(3) At
the end of each financial year, the balance sheet shall be prepared and any
un-spent remaining amount and all other collections including Central Research
Fund shall be securely invested only in Government schemes in order to achieve
self-sufficiency of the Authority.
(4) A
separate pension endowment fund shall be established for the payment of
pensions of employees recruited in the Authority.
20.
Fees and other charges to be levied by the Authority.(1) The Authority shall
levy and collect such fees, in respect of any of its functions at such rates as
may be determined, from time to time by the Authority, with the approval of the
Policy Board, in accordance with rules.
(2) The
Central Research Fund fee shall be deposited in the non-lapsable sub-account of
the Authority to be utilized as per existing rules.
(3) The
existing Central Research Fund kept with the Federal Government shall be
transferred to the Authority immediately after the notification of
establishment of the Authority.
21.
Budget.(1) The Authority
shall, in respect of each financial year prepare on such date as may be
prescribed a statement of the estimated receipts and expenditure, including the
revised and estimated budgets, requirements of grant-in-aid from Federal
Government, and foreign exchange for the next financial year for consideration
and approval of the Board. Any foreign exchange requirements within the overall
annual approved budget by the Board shall be sent to Federal Government for
appropriate provision and allocation.
(2) It
shall not be necessary for the Authority to take prior approval from the
Government to spend money from its own generated funds, and shall practice
financial freedom as the Board deem fit for furtherance of its functions.
22.
Accounting and Audit.(1) The Authority may
open its accounts with any scheduled Bank or financial institution within the
framework of the prescribed rules. The Authority may approach the Government,
for the grant of initial funds in this respect.
(2) The
accounts of the Authority shall be maintained as a double entry system and in
the manner prescribed by the Controller General of Accounts.
(3) The
Authority shall cause to be carried out audit of its accounts by one or more
auditors registered as chartered accountants within the meaning of the
Chartered Accountants Act, 1961 (X of 1961).
(4)
Notwithstanding the audit provided by in sub-section (3) the Auditor General
shall have the power to audit or cause to be audited the accounts of the Authority.
(5) A
copy of the audit report shall be sent to the Federal Government along with the
comments of the Authority.
(6) The
Authority shall take the requisite steps for the rectification of any objection
raised by the Auditor-General of
CHAPTER-IV
RULES AND
REGULATIONS
23.
Power to make rules. The Authority may, with
the approval of the Federal Government, by notification in the official
Gazette, make rules for carrying out the purposes of this Act.
24.
Power to make regulations. The Authority may, by
notification in the official Gazette, with the approval of the Board, make
regulations, for its internal working and terms and condition of employees not
inconsistent with the provisions of the Act or the rules, for the carrying out
of its functions under this Act.
CHAPTER-V
MISCELLANEOUS
25.
Submission of annual reports and returns.(1) Within three months
of the conclusion of each financial year, the Authority shall submit an annual
report to the Federal Government in respect of the activities of the Authority
including the status of its existing programs, projects and further plans
formulated in furtherance of its aims and objectives.
(2) The
Federal Government may require the Authority to furnish:-
(a) any return, statement,
estimate, statistics or other information regarding any matter under the
control of the Authority;
(b) a report on any
subject related to the Authority; and
(c) a copy of any document
in the custody of the Authority;
(3) The
Authority shall expeditiously comply with such directions.
26.
Power to call for information. The Authority may call
for any person, involved directly or indirectly, and reasonably believed to
having such information in his control or possession which is required for
carrying out the purposes of this Act. The person so called upon to provide
such information shall do so within the period prescribed by the Authority and
in case of failure to do so he shall be punished by imposition of such penalty
which may not exceed one hundred thousand rupees.
27.
Offences, penalties etc.(1) The offences shall
be such as specified in Schedule-III.
(2) The
prohibition specified in Schedule-II shall be punished in accordance with
Schedule-III.
28.
Offences by companies etc. Where the person guilty
of an offence under this Act or the Drugs Act, 1976 (XXXI of 1976), is a
company, corporation, firm or institution, every director, partner and employee
of the company, corporation, firm or institution with whose knowledge or
consent the offence was committed shall be guilty of the offence.
29.
Cognizance of offences. Cognizance of offences
shall be taken by the Inspector in the manner specified in Schedule-IV.
30.
Complaints.(1) Any aggrieved
person may file a written complaint with the Authority against contravention of
any provision of this Act or any law specified in Schedule-VI.
(2) The
Authority shall, on receipt of a complaint cause it to be investigated as may
be prescribed and provide an opportunity to the complainant as well as the
person against whom such complaints has been made. The Authority may, on completion
of investigation, take any action as may be prescribed under this Act or as the
case may be subject to the provisions of any law specified in the Schedule-VI.
(3)
Appeals against the decisions of the Authority shall be referred to the Board,
which shall formulate an Appellate Board from among its members, who shall
decide the case on merit.
31.
Confidential information.(1) Except as provided
under the regulations, no person shall communicate, or allow to be
communicated, any record or information obtained under this Act to a person not
legally entitled to that record or information or allows any person not legally
entitled to that record or information to have access to any record obtained
under this Act.
(2) A
person who knowingly receives records or information obtained under this Act
shall hold the record or information subject to the same restrictions under
sub-section (1) as apply to the person from who the records or information were
received.
32.
Act not to override other laws.(1) The provisions of
this Act shall be in addition to and not in derogation of the provisions made
in the Drugs Act, 1976 (XXXI of 1976) and any other law for the time being in
force.
(2) In
case of inconsistency between the provisions of this Act and any other law for
the time being in force, the provisions of this Act shall prevail.
33.
Recovery of arrears. All amounts due to the Authority may be recovered as
arrears of land revenue.
34.
Indemnity. No suit prosecution or
other legal proceeding shall lie against any person for anything which is in
good faith done or intended to be done under this Act or any rules or
regulations made there under.
35.
Power to amend Schedule. The Federal Government
may, by notification in the official Gazette, amend the Schedule so as to add
any entry thereto or modify or omit any entry therefrom on the recommendation
of the Board.
36.
Removal of difficulties. If any difficulty
arises in giving effect to any of the provisions of this Act, the Federal
Government may make such Order by notification in the Official Gazette, not
inconsistent with the provisions of this Act, for the purpose of removing the
difficulty.
37.
Employment under the Authority to be employment under the Federal Government. Every employment under
the Authority shall, for the purpose of Pakistan Essential Services
(Maintenance) Act, 1952 (LIII of 1952), be deemed to be employment under
Federal Government and the said Act shall have effect accordingly.
38.
Act X of 2012 not to apply to the Authority. Nothing contained in the Industrial Relation Act (X of
2012), shall apply to or in relation to the Authority or any of the officers
and employees of the Institute.
39.
Co-operation with international organizations. The Authority may, subject to the prior approval of
the Federal Government, co-operate with any foreign authority or international
organization in the field of health on the terms and conditions of any program
or agreement for co-operation to which such authority or organization is a
party, or pursuant to any other international agreement made or after the
commencement of this Act.
40.
Repeal and Savings.(1) The Drug Regulatory
Agency of Pakistan Ordinance, 2012 (Ordinance I of 2012) is hereby repealed.
(2) Notwithstanding
the repeal of the Drug Regulatory Agency of Pakistan Ordinance, 2012 (Ordinance
I of 2012) by sub-section (1),---
(a) any license to
manufacture or any registration or maximum retail price fixed for sale issued
thereunder to any person, or for the revalidation of an license or registration
issued earlier under the Act, for which an application has been made to the
Licensing Board, Registration Board, and Drug Pricing Committee as the case may
be within the specified time, shall continue to be valid;
(b) any license for import
or export or sale of drugs issued thereunder to any person, shall, unless it
expires earlier under the terms thereof, continue to be valid for such periods
as the Federal Government, may by notification in the official Gazette, specify
in this behalf.
(3) All
such actions of the Federal Government as mentioned in sub-section (2) since
20th April, 2010 shall be deemed to have validly made under this Act.
41.
Policy Directive of Federal Government.(1) The Federal
Government may issue policy directives in accordance with the law and
Constitution to the Board in respect of any of its activities, powers and
functions and whose compliance shall be binding on the Authority, within a
stipulated time.
(2)
Notwithstanding anything contained in sub-section (1) if there is any
difficulty in implementation of the directions and guidelines of the Policy
Board or the Federal Government, the Authority shall refer the case back to the
Federal Government for its review specifying reasons for non-implementation,
within the stipulated time, whose decision in this respect shall be final.
42.
Winding up of Authority. No provision of any law relating to winding up of
bodies corporate shall apply to the Authority. The Authority shall only be
wound up by the law to be enacted by the Parliament for winding up of the
Authority).
SCHEDULE-I
[See Section 2 (v, xii,
xviii, xix, & xxviii)]
(1)
Biological drugs produced by biological systems and which require
standardization by biological assays according to the relevant and updated
recommendations of the World Health Organization published in Technical Report
Series and Biological Standardization Report and includes,---
(a) blood products
including Plasma, Albumin, Clotting Factors, Factors VIII, IX, Mixed Clotting
Factors Tractions, Fibrinogens, Immunoglobulins:
(b) immunological products
including Antisera, Antitoxins, specific Immunoglobulins;
(c) in vivo diagnostics
including Tuberculins, Lepronin, Histoplasmin, Coccidioidin, Allergens,
Allergens Extracts, Antibodies conjugated with isotopes for imaging studies;
(d) antigens,
cytokines/antibodies/eels injected to elicit a biological response;
(e) vaccines, including:---
(i) bacterial vaccines
including live, killed whole cell, protein sub-unit, polysacchrid or glyco-conjugate,
toxin derivatives, and rDNA biotechnology developed.
(ii) viral vaccines
including live, inactivated, sub-unit, DNA, conjugated;
(iii) polyvalent
combinations of vaccines containing combination of vaccines defined in e (i)
and d(ii).
(f) toxins and venoms
including snake venoms, scorpion venoms etc;
(g) immunostimulanls of
biological origin including BCG vaccine for immunothcrapy;
(h) biotechnology products
which are primarily manufactured using recombinant DNA, recombinant RNA,
hybridoma technology or other processes involving site specific genetic
manipulation techniques.
(i) human interferons,
natural hormones, recombinant antibodies, monoclonal antibodies and derivatives
gene therapy products;
(2) “Biological
Drugs (Finished form)”, are Biological Drugs that are defined in sub-section
(1) above and are manufactured, packed by the manufacturer under his
responsibility of quality assurance and is further released by the National
Control Authority or the National Control Laboratory of the country of origin
under the World Health Organization's Lot Release system of evaluation.
(3) “Biological
Drugs (Ready-to-fill form)”, are Biological Drugs that are defined in
sub-section (1) above but are manufactured at one site in the form of a “Ready-to-fill
Bulk” but are transferred to another site for final filling, labeling,
packaging and quality control of the finished form. No further formulation or
dilution of the Ready-to-fill bulk is allowed in this case of manufacture. The
final product is released by the
(4) “Biological
Drugs (Concentrated form)”, are Biological Drugs that are defined in
sub-section (1) above that are manufactured at one site but are stored in the
form of Concentrated-Bulk of the active ingredient at controlled temperatures.
Such Concentrated-Bulk may be transferred to any other site under temperature
controlled conditions for further dilution,
stabilization,
filling and packaging. The diluted and stabilized bulk requires its own set of
quality control test and the final finished form of such Biological Drugs under
go another set of complete quality control tests. The final product is released
by the
(5)
''Biological Drugs (Naked vials)”, are Biologicals Drugs that are defined in
sub-section (1) above that are manufactured and filled at one site but the
final containers are neither labeled nor packed in cartons. These drugs are
imported in unlabeled vials and are labeled and packed in carton locally. In
such cases at least an identity test is required to confirm the positive
identification of the required antigen. The final product is released by the
(6)
Originator Biological Drugs means a biological drug which has been licensed by
the national regulatory authorities on the basis of a full registration
dossier; i.e. the approved indication(s) for use were granted on the basis of
full quality, efficacy and safety data:---
(a) reference
biotherapeutic product (RBP) means an originator biological drug product that
was licensed on the basis of a full registration dossier. It does not refer to
measurement standards such as international, pharmacopoeial, or national
standards or reference standards;
(b) biosimilar biological
drugs mean Similar Biotherapeutic Product (SBP) which is similar in terms of
quality, safety and efficacy to an already licensed reference biotherapeutic
product;
(c) similarity means
absence of a relevant difference in the parameter of interest.
(7) No
human biological drug is allowed sale and use until a “Lot Release Certificate”
from the Federal Government Analyst of the National Control Laboratory for
Biologicals,
(8)
Pharmaceutical dossier includes a set of documents submitted by a Person for
the registration of a therapeutic good, containing complete information about:---
(a) muster formula;
(b) all ingredients both
active pharmaceutical ingredients and inactive excipients added with their
safety profile data;
(c) complete manufacturing
procedure of the drug, biological or medical device;
(d) quality control steps
and procedures at each level of raw material selection, in-process testing,
finished drug testing, and stability testing;
(e) clinical trial data
and published reports about the safety and efficacy of the drug;
(f) complete details of
manufacturing plant and equipment, quality control laboratories and equipment;
(g) ware-houses capacities
and facilities; details of human resources available and the latest cGMP report
shall also be part of this document set;
(h) any other information
required by the registration board for establishing the safety, efficacy,
bioavailability, bioequivalence, or biosimilarity of the drug.
2.
DRUG includes:---
(a) any substance or
mixture of substances that is manufactured, sold, stored, offered for sale or
represented for internal or external use in the treatment, mitigation,
prevention or diagnosis of diseases, an abnormal physical state, or the
symptoms thereof in human beings or animals or the restoration, correction, or
modification of organic functions in human beings or animals, including
substance used or prepared for use in accordance with the Ayurvedic, Unani,
Homoeopathic, Chinese or biochemic system of treatment except those substances
and in accordance with such conditions as may be prescribed;
(b) abortive and
contraceptive substances, agents and devices, surgical ligatures, sutures,
bandages, absorbent cotton, disinfectants, bacteriophages,
adhesive plasters, gelatin capsules and antiseptic solution;
(c) such substances
intended to be used for the destruction or repulsion of such vermin, insects,
rodents and other organism as cause, carry or transmit disease in human beings
or animals or for disinfection in residential areas or in premises in which
food is manufactured, prepared or kept or stored;
(d) such pesticides as may
cause health hazard to the public;
(e) any substance
mentioned as monograph or as a preparation in the Pakistan Pharmacopoeia or the
Pakistan National Formulary or the International Pharmacopoeia or the British
Pharmacopoeia or the British Pharmaceutical Codex or the United States
Pharmacopoeia or the National Formulary of the United States, whether alone or
in combination with any substance exclusively used in the Unani, Ayurvedic,
Homoeopathic, Chinese or Biochemic system of treatment, and intended to be used
for any of the purposes mentioned in sub-Clauses (a), (b) and (c); and
(f) any other substance
which the Federal Government may by notification in the official Gazette,
declare to be a drug for the purpose of this Act.
3.
MEDICAL DEVICES include,---
(a) instruments, medical
equipment, implants, disposables and software, used mainly for the purpose of
diagnosis, monitoring and treatment of disease, or
(b) any other item which
the Federal Government may, by notification in the official Gazette, declare as
medical device;
4.
MEDICATED COSMETICS include Cosmetics containing drugs and are defined as
articles containing active drug ingredients intended to be rubbed, poured,
sprinkled, or sprayed on, or introduced into, or otherwise applied to human
body or part thereof for cleansing, beautifying, promoting attractiveness, or
altering the appearance, and articles intended for use as a component of any
such articles; except that such term shall not include soap.
SCHEDULE-II
[See Section 2(xxx)]
PROHIBITIONS
A. Import, manufacture
and sale of therapeutic goods:---
(1) No person shall
himself or by any other person on his behalf,---
(a) Export, import or
manufacture for sale or sell,---
(i) any spurious
therapeutic good;
(ii) any counterfeit
therapeutic good;
(iii) any misbranded therapeutic good;
(iv) any adulterated
therapeutic good;
(v) any substandard
therapeutic good;
(vi) any therapeutic good
after its expiry date;
(vii) any therapeutic good
which is not registered or is not in accordance with conditions of registration
as disclosed in the registration dossier and that has undergone pharmaceutical
evaluation;
(viii) any therapeutic good
which, by means of any statement, design or device accompanying it or by any
other means, purports or claims to cure or mitigate any such disease or
ailment, or to have any such other effect, as may be prescribed;
(ix) any drug if it is
dangerous to health when used in the dosage or with the frequency, or for the
duration specified, recommended or suggested in the labeling thereof; or
(x) any therapeutic good
in contravention of any of the provisions of this Act or rules made thereunder;
(b) manufacture for sale
any therapeutic good except under, and in accordance with the condition of a
license issued under this Act;
(c) sell any therapeutic
good except under, and in accordance with the conditions of a license issued
under this Act;
(d) import or export any
therapeutic good the import or export of which is prohibited by or under this
Act;
(e) import or export any
therapeutic good drug for the import or export of which a license is required,
except under, and in accordance with the conditions of, such license;
(f) supply an incorrect,
incomplete or misleading information, when required to furnish any information
under this Act or the rules;
(g) peddle, hawk or offer
for sale any therapeutic good in a park, or public street or on a highway
footpath or public transport or conveyance;
(h) import, manufacture
for sale, or sell any substance, or mixture of substances, which is not a
therapeutic good but is presented in a form or a manner which is intended or
likely to cause the public to believe it to be a therapeutic good;
(i) sell any therapeutic
good without having warranty in the prescribed form bearing the name and batch
number of the therapeutic good issued--
(i) in the case of a
therapeutic good manufactured in Pakistan, by the manufacturer holding a valid
license to manufacture therapeutic good and permission to manufacture that
therapeutic good or by his authorized agent;
(ii) in the case of an
imported drug, by the manufacture or importer of that therapeutic good or if
the therapeutic good is imported through an indenter by such indenter; and
(iii) apply an incorrect
batch number to a therapeutic good.
(2)
Nothing in Paragraph (1) shall apply to the manufacture of small quantities of
any therapeutic good for the purpose of clinical trial examination, test,
analysis or personal use in small quantities.
B.
Control of advertisement:---
No
person shall himself or by any other person on his behalf advertise, except in
accordance with such conditions as may be prescribed,---
(a) any therapeutic good;
(b) any substance used or
prepared for use in accordance with the Ayurvedic, Unani, Homoeopathic, Chinese
or Biochemic system of treatment or any other substance or mixture of substances
as may he prescribed;
(c) any remedy, treatment
or offer of a treatment for any disease.
Explanation.- For the purpose of this
entry “Advertise” means to make any representation by any means whatsoever for
the purpose of promoting directly or indirectly the sale or disposal of
therapeutic good, a substance or a mixture of substances, a remedy or a
treatment except the display of sign boards for a clinic, a dispensary or a
hospital or such other institution offering treatment.
C.
Control of samplings:---
No
person shall distribute or cause to be distributed any therapeutic good as a
sample except in accordance with such conditions as may be prescribed.
D. Control of
printing of labeling:---
No
person shall print any label in respect of any therapeutic good which is
required to be registered under this Act but is not so registered after the
date fixed by the Federal Government under sub-section (6) of Section 7 of Act,
or for a person who does not possess a license under that Act to manufacture
that therapeutic good.
SCHEDULE-III
[See Section 27]
OFFENCE
(1)
Whoever himself or by any other person on his behalf,---
(a) exports, imports,
manufactures for sale or sells any spurious therapeutic good or any therapeutic
good which is not registered;
(b) manufactures for sale
any therapeutic good without a license;
(c) imports without
license any therapeutic good for the import of which a license is required;
Shall be punishable
with imprisonment for a term which shall not be less than three years or more
than ten years and with fine which may extend to ten lakh rupees:---
Provided
that the
(2)
Whoever himself or by any other person on his behalf,---
(a) imports, manufactures
for sale or sells any counterfeit therapeutic good; or
(b) gives to the purchaser
a false warranty in respect of any therapeutic good sold by him that the
therapeutic good does not in any way contravene the provisions
of Schedule II and is not able to prove that, when he gave the warranty, he had
good and sufficient reason to believe the same to be true; or
(c) applies or permits to
be applied to any therapeutic good sold, or stocked or exhibited for sale, by
him, whether the container or a label or in any other manner, a warranty given
in respect of any other therapeutic good; or
(d) imports, manufactures
for sales or sells any therapeutic good under a name other than the registered
name; or
(e) exports, imports,
manufactures for sale or sells any therapeutic good with which any substance,
which should not actually be its component, or has been mixed or packed it so
as to reduce its quality or strength or for which any such substance has been
substituted wholly or in part,
shall be punishable
with imprisonment for a term which may extend to seven years, or with fine
which may extend to five lakh rupees or with both.
(3) Obstruction
of Inspector.--Whoever obstructs an Inspector in the exercise of any power
conferred upon him by or under this Act, or disobeys the lawful authority of
any Inspector, shall be punishable with imprisonment for a term which may
extend to one year, or with fine which may extend to one lakh rupees, or with
both.
(4) Contravention
of rules.--Subject to the provisions of Clauses (1), (2) and (3), whoever
himself or by any other person on his behalf contravenes any of the provisions of
this Act or any rule shall be punishable with imprisonment for a term which may
extend to five years, or with fine which may extend to one lakh rupees, or with
both.
(5) Penalty
for subsequent offence.--Whoever having been convicted of an offence under Clause
(1) of Schedule-Ill is convicted for a subsequent offence under that section
shall be punishable with imprisonment for life or with imprisonment which shall
not be less than five years and with fine which may extend to five hundred
thousand rupees.
(6) Penalty
for violating the prohibitions.--Whoever himself or by any other person on
his behalf violates any prohibitions specified in Schedule-II shall be punished
with imprisonment for a term up to five years and with fine up to five hundred
thousand rupees.
SCHEDULE-IV
[See Section 29]
COGNIZANCE OF
OFFENCES
(1)
Subject to the provisions of Schedule-V no prosecution shall be instituted
under this Act except,---
(a) by a Federal
Inspector, where the prosecution is in respect of a contravention of Clause (h)
of Paragraph (1) of heading A of Schedule-II or any of the provisions of this
Act or the rules relating to the import or export of therapeutic goods or the
manufacture for sale, or sale, of a therapeutic good which is not for the time
being registered or for the manufacture for sale of which a license is not for
the time being in force; or
(b) by a Provincial
Inspector:---
Provided
that, where the public interest so requires, the Federal Inspector may, with
the prior permission of the Registration Board or Licensing Board as the case
may be, institute a prosecution for a contravention of any other provision of
this Act and The Drugs Act, 1976 (XXXI of 1976).
(2)
Notwithstanding anything contained in the Code of Criminal Procedure, 1898 (Act
V of 1898):---
(a) an offence punishable
under Schedule-III other than an offence mentioned in Clause (1) of that
Schedule shall be non-cognizable, and
(b) no Court other than a
Drug Court established under The Drugs Act, 1976, (XXXI of 1976) shall try an
offence punishable under this Act and Drugs Act, 1976 (XXXI of 1976);
(c) nothing contained in
this Schedule shall be deemed to prevent any person from being prosecuted under
any other law for any act or omission which constitutes an offence punishable
under this Act or The Drugs Act, 1976 (XXXI of 1976) or to require the transfer
to a drug Court of any case which may be pending in any Court immediately
before the establishment of Drug Court.
SCHEDULE-V
[See Section 2(xvi)]
POWERS OF INSPECTORS
(1)
Subject to the provisions of this Schedule and of any rules made in this
behalf, an Inspector may, within the local limits for which he is appointed,
and in any other area within the permission of the licensing Authority or Licensing
Board as the case may be,---
(a) inspect any premises
where in any therapeutic good is manufactured, the plant and process of
manufacture, the means employed, for standardizing and testing the therapeutic
goods and all relevant records and registers;
(b) inspect any premises
wherein any therapeutic good is sold or is stocked or exhibited for sale or is
distributed, the storage arrangements and all relevant records and registers;
(c) take samples of any
therapeutic good which is being manufactured, or being sold or is stocked or
exhibited for sale or is being distributed;
(d) enter and search, with
such assistance, if any, as he considers necessary, any building, vessel or
place, in which he has reason to believe that an offence under this Act or any
rules has been or is being committed or may continue to be committed;
(e) call any person to be
present as witness in the course of search or seizure or in connection with any
other matter where the presence of witnesses is necessary;
(f) seize such therapeutic
good and all materials used in the manufacture thereof and any other articles,
including registers cash memos, invoices and bills, which he has reason to
believe may furnish evidence of the commission of an offence punishable under
this Act or any rules;
(g) require any person to
appear before him at any reasonable time and place to give statement,
assistance or information relating to or in connection with
the investigation of any offence under this Act and the Drugs Act, 1976 (XXXI
of 1976) or the rules:---
Provided that the
exemption under Sections 132 and 133 of the Code of Civil Procedure, 1908 (Act
V of 1908), shall be applicable to requisitions for attendance under this
Schedule;
(h) lock and seal any
factory, laboratory, shop, building, store-hose or godown, or a part thereof,
where any therapeutic good is or is being manufactured, stored, sold or
exhibited for sale in contravention of any of the provisions of this Act, the
Drugs Act, 1976 or the rules;
(i) forbid for a
reasonable period, not exceeding four weeks or such further period, which shall
not be more than three months, as the Inspector may, with the approval of the
Provincial Quality Control Board, the Licensing Board, the Registration Board,
as the case may be, specify, any person in charge of any premises from removing
or dispensing of any therapeutic good, article or other thing likely to be used
in evidence of the commission of an offence under this Act or the rules; and
(j) exercise such other
powers as may be necessary for carrying out the purposes of this Act or any
rules:---
Provided that the
powers under Paragraph (f) to (j) shall be exercisable only by an Inspector
specifically authorized in this behalf, by an order in writing, by the
Government appointing him, subject to such conditions as may be specified in
such order:---
Provided further
that the power under Paragraph (h) may be exercised by an Inspector not
authorized as aforesaid where the contravention is of a provision which
requires a license to be obtained for the manufacture, storage or sale of drug.
(2) The
provisions of the Code of Criminal Procedure, 1898 (Act V of 1898), insofar as
they are not inconsistent with the provisions of this Act and The Drugs Act,
(XXXI of 1976), shall apply to searches and seizures made under this Act.
(1)
Where an Inspector seizes any therapeutic good or any other article under this
Schedule he shall tender a receipt therefore in the prescribed form.
(2)
Where an Inspector takes a sample of a therapeutic good for the purpose of test
or analysis, he shall intimate such purpose in writing in the prescribed form
to the person from whom he takes it and, in the presence of such person unless
he willfully absents himself, shall divided the sample into four portions and
effectively seal and suitable mark the same and permit such persons to add his
own seal, if any, and mark to all or any of the portions so sealed and marked:
Provided
that, where the sample is taken from premises whereon the drug is being
manufactured, it shall be necessary to divide the sample into three portions
only:---
Provided
further that, where the therapeutic good is made up in containers of small
volume, instead of dividing a sample as aforesaid, the Inspector may, and if
the therapeutic good be such that it is likely to deteriorate or be otherwise
damaged by exposure shall, take three or four, as the case may be, of the said
containers after suitably marking the same and, where necessary, sealing them:---
Provided
also that if the contents of one container are insufficient for the laboratory
test and analysis, the Inspector may increase the number of the containers in
order to make the sample sufficient for this purpose.
(3) The
Inspector shall return one portion of a sample so divided or one container, as
the case may be, to the person from whom he takes it, and shall retain the
remainder and dispose of the same within seven days as follows, namely,---
(a) one portion of sample
he shall send to the Government Analyst concerned for test and analysis;
(b) the second he shall
send to the Chairman, Provincial Quality Control Board or the Licensing Board
or the Registration Board, as the case may be; and
(c) the third, where
taken, he shall send to the warrantor, if any, named under proviso to
sub-section (3) of Section 32 of The Drugs Act, 1976 (XXXI of 1976).
(4) Where an Inspector seizes any therapeutic good
containing any filthy or putrid substance, vermin, worm, rodent, insect or any
foreign matter which is visible to the naked eye, and the sample is such that
it cannot or need not be divided, he shall effectively seal and suitably mark
the same and permit the person from whom he seizes the therapeutic good to add
his own seal, if any, and mark to it and shall produce the same before the Drug
Court, or the Provincial Quality Control Board, or the Licensing Board or the
Registration Board, as the case may be, before which proceedings are instituted
or action is initiated in respect of the drug.
(5)
Where an Inspector takes any action under section this Schedule,---
(a) he shall as soon as
practicable ascertain whether or not the therapeutic good contravenes any of
the provisions of this Act and, it is ascertained that the drug does not so
contravene, he shall forthwith revoke the order passed under the said section
or, as the case may be, take such action as may be necessary for the return of
the stock seized and payment for the samples taken, under intimation to the
Board concerned;
(b) if he seizes the stock
of the therapeutic good he shall, as soon as may be inform the Board concerned
and take its order as to the custody thereof:---
Provided
that where a Federal Inspector is not competent to take action under
Schedule-IV, he shall as soon as may be, report the matter and hand over the
stock, if any, to the Provincial Inspector for further action under this Act or
The Drugs Act, 1976.
(6) The
Provincial Inspector on finding any contravention of this Act or the Drugs Act,
1976 (XXXI of 1976) shall, unless the Board otherwise directs, always refer the
case to the Provincial Quality Control Board and seek orders as to the action
to be taken in respect of such contraventions.
(7) The
Federal Inspector on finding any contravention of this Act or the Drugs Act,
1976 (XXXI of 1976) for which he is authorized shall unless otherwise directed,
always refer the case to the Licensing Board or the Registration Board or any
other authority as may be specified for the purpose and seek any further orders
as to the action to be taken in respect of such contravention.
SCHEDULE-VI
[See Section 2(i)]
(1) THE DRUGS ACT, (XXXI of 1976).
(2) Rules made under the Drugs Act, 1976 (XXXI of
1976).
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